Gilead registers two Phase 2 trials: PBC combo study and weekly oral HIV regimen

Gilead added two Phase 2 studies to ClinicalTrials.gov this week, neither of which has begun enrollment.

• Gilead registered a Phase 2 trial (NCT07841977) testing seladelpar combined with cilofexor against seladelpar alone and placebo in primary biliary cholangitis. The study aims to find out if adding cilofexor to seladelpar produces a bigger drop in alkaline phosphatase than seladelpar alone, while also tracking safety and tolerability of the combination.¹ The trial is estimated to enroll 132 participants.¹
• Gilead also registered "Substudy-01" (NCT07841990) of a Phase 2 platform study evaluating oral long-acting HIV-1 regimens. The substudy will test switching virologically suppressed people on Biktarvy to weekly oral regimens combining investigational GS-3242 with lenacapavir, compared with staying on daily Biktarvy.² Gilead's stated goal is comparing efficacy of each long-acting oral regimen against continued B/F/TAF in virologically suppressed participants at Week 24,² with an estimated enrollment of 125 participants.²